AU, UK: Use is not recommended.
US: This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Comments:
-Female patients of childbearing potential should use effective contraception during therapy.
-Male patients should not father a child during therapy and for up to 6 months after the last dose.
-Local protocol should be consulted regarding contraception timing.

Animal studies have revealed evidence of teratogenicity (skeletal abnormalities). There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

This drug was excreted into the milk of rats, resulting in maternal milk levels 3 times greater than maternal blood levels.

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-The US CDC, American Academy of Pediatrics, and manufacturer advise HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected.

See references